{"schemaVersion":"jobsearcher.job.v1","id":"6454d2d41a1e8eb5a7255198","url":"https://jobsearcher.com/jobs/6454d2d41a1e8eb5a7255198","canonicalUrl":"https://jobsearcher.com/jobs/6454d2d41a1e8eb5a7255198","title":"Validation Engineer","description":"Job DescriptionTitle: Validation Engineer (Injection Molding / Injectables / Automation)\n\nLocation:Buffalo Grove\n\nHire Type: Contract\n\nShift: 1st Shift / Standard Business Hours\n\nCompensation:$55-70/hr.\n\nBenefits:\n\nAs a contract employee of Sterling, you are eligible to receive a Full Employee Benefits Package that includes paid time off, paid holidays, 3 medical plans to choose from, dental & vision plans, 401(k), and an Employee Stock Ownership (ESOP) plan.\n\nMust Have Skill Set:\n\n5+ years of validation engineering experience in regulated manufacturing environments\n\nHands-on experience with injection molding processes and equipment validation\n\nExperience supporting injectable pharmaceutical, biologics, or sterile manufacturing operations\n\nStrong knowledge of IQ/OQ/PQ, CSV, and lifecycle validation principles\n\nExperience validating automated manufacturing equipment, PLC-controlled systems, or integrated automation platforms\n\nWorking knowledge of GMP, FDA, 21 CFR Part 11, and validation documentation requirements\n\nExperience with process equipment qualification, protocol execution, deviation investigations, and change control\n\nStrong technical writing and cross-functional communication skills\n\nOverview:\n\nWe are seeking a Validation Engineer with experience in injection molding, injectable manufacturing, and automation systems to support validation activities within a regulated manufacturing environment. This role will be responsible for qualification and validation of manufacturing equipment, automated production systems, process improvements, and facility-related projects.\n\nThe ideal candidate will have hands-on experience validating injection molding equipment used in medical device or pharmaceutical production, along with familiarity supporting sterile/injectable manufacturing processes and automation-driven production environments. This individual will partner closely with engineering, manufacturing, quality, automation, and project teams to ensure compliant implementation and operational readiness of equipment and processes.\n\nJob Duties:\n\nDevelop, execute, and approve validation protocols including IQ, OQ, PQ, TMV, and process validation documentation\n\nSupport qualification and validation of injection molding equipment, automation systems, and manufacturing process equipment\n\nValidate production equipment used in injectable pharmaceutical or sterile manufacturing environments\n\nCollaborate with automation engineers to qualify PLC-controlled systems, HMI interfaces, SCADA systems, and integrated manufacturing equipment\n\nSupport commissioning and startup activities for new manufacturing equipment and capital projects\n\nExecute risk assessments, FAT/SAT activities, and validation impact assessments\n\nInvestigate validation deviations, implement CAPAs, and support change control activities\n\nEnsure validation deliverables align with internal SOPs, GMP standards, FDA regulations, and industry best practices\n\nPartner cross-functionally with Quality, Manufacturing, Engineering, Automation, and Project Management teams\n\nReview P&IDs, equipment specifications, URS documents, and functional design specifications\n\nSupport process improvements and revalidation efforts tied to manufacturing changes or equipment upgrades\n\nMaintain accurate validation documentation and support audit readiness activities\n\nQualifications:\n\nRequired Qualifications:\n\nBachelor’s degree in Engineering, Life Sciences, or related technical discipline\n\n5+ years of validation engineering experience in pharmaceutical, medical device, biotech, or regulated manufacturing environments\n\nDirect experience with injection molding equipment validation\n\nExperience supporting injectable, sterile, or aseptic manufacturing operations\n\nStrong knowledge of validation lifecycle methodology and GMP compliance\n\nExperience with automated manufacturing equipment and control systems\n\nStrong protocol writing, execution, and technical documentation experience\n\nAbility to troubleshoot technical issues and work effectively in cross-functional teams\n\nPreferred Qualifications:\n\nExperience in medical device manufacturing involving molded plastic components\n\nFamiliarity with DeltaV, Allen-Bradley PLCs, Siemens, SCADA, or MES systems\n\nExperience supporting equipment used in cleanroom or aseptic manufacturing environments\n\nExposure to packaging validation, serialization, or automated inspection systems\n\nPrevious experience supporting FDA inspections or internal audits","company":"Sterling Engineering","rawCompany":"sterling engineering","city":"Wheeling","state":"IL","isRemote":false,"isActive":false,"createdAt":"2026-10-22T01:35:02.370Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"334513","title":"Instruments and Related Products Manufacturing for Measuring, Displaying, and Controlling Industrial Process Variables","slug":"instruments-and-related-products-manufacturing-for-measuring-displaying-and-controlling-industrial-process-variables"},{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Validation Engineer","description":"Job DescriptionTitle: Validation Engineer (Injection Molding / Injectables / Automation)\n\nLocation:Buffalo Grove\n\nHire Type: Contract\n\nShift: 1st Shift / Standard Business Hours\n\nCompensation:$55-70/hr.\n\nBenefits:\n\nAs a contract employee of Sterling, you are eligible to receive a Full Employee Benefits Package that includes paid time off, paid holidays, 3 medical plans to choose from, dental & vision plans, 401(k), and an Employee Stock Ownership (ESOP) plan.\n\nMust Have Skill Set:\n\n5+ years of validation engineering experience in regulated manufacturing environments\n\nHands-on experience with injection molding processes and equipment validation\n\nExperience supporting injectable pharmaceutical, biologics, or sterile manufacturing operations\n\nStrong knowledge of IQ/OQ/PQ, CSV, and lifecycle validation principles\n\nExperience validating automated manufacturing equipment, PLC-controlled systems, or integrated automation platforms\n\nWorking knowledge of GMP, FDA, 21 CFR Part 11, and validation documentation requirements\n\nExperience with process equipment qualification, protocol execution, deviation investigations, and change control\n\nStrong technical writing and cross-functional communication skills\n\nOverview:\n\nWe are seeking a Validation Engineer with experience in injection molding, injectable manufacturing, and automation systems to support validation activities within a regulated manufacturing environment. This role will be responsible for qualification and validation of manufacturing equipment, automated production systems, process improvements, and facility-related projects.\n\nThe ideal candidate will have hands-on experience validating injection molding equipment used in medical device or pharmaceutical production, along with familiarity supporting sterile/injectable manufacturing processes and automation-driven production environments. This individual will partner closely with engineering, manufacturing, quality, automation, and project teams to ensure compliant implementation and operational readiness of equipment and processes.\n\nJob Duties:\n\nDevelop, execute, and approve validation protocols including IQ, OQ, PQ, TMV, and process validation documentation\n\nSupport qualification and validation of injection molding equipment, automation systems, and manufacturing process equipment\n\nValidate production equipment used in injectable pharmaceutical or sterile manufacturing environments\n\nCollaborate with automation engineers to qualify PLC-controlled systems, HMI interfaces, SCADA systems, and integrated manufacturing equipment\n\nSupport commissioning and startup activities for new manufacturing equipment and capital projects\n\nExecute risk assessments, FAT/SAT activities, and validation impact assessments\n\nInvestigate validation deviations, implement CAPAs, and support change control activities\n\nEnsure validation deliverables align with internal SOPs, GMP standards, FDA regulations, and industry best practices\n\nPartner cross-functionally with Quality, Manufacturing, Engineering, Automation, and Project Management teams\n\nReview P&IDs, equipment specifications, URS documents, and functional design specifications\n\nSupport process improvements and revalidation efforts tied to manufacturing changes or equipment upgrades\n\nMaintain accurate validation documentation and support audit readiness activities\n\nQualifications:\n\nRequired Qualifications:\n\nBachelor’s degree in Engineering, Life Sciences, or related technical discipline\n\n5+ years of validation engineering experience in pharmaceutical, medical device, biotech, or regulated manufacturing environments\n\nDirect experience with injection molding equipment validation\n\nExperience supporting injectable, sterile, or aseptic manufacturing operations\n\nStrong knowledge of validation lifecycle methodology and GMP compliance\n\nExperience with automated manufacturing equipment and control systems\n\nStrong protocol writing, execution, and technical documentation experience\n\nAbility to troubleshoot technical issues and work effectively in cross-functional teams\n\nPreferred Qualifications:\n\nExperience in medical device manufacturing involving molded plastic components\n\nFamiliarity with DeltaV, Allen-Bradley PLCs, Siemens, SCADA, or MES systems\n\nExperience supporting equipment used in cleanroom or aseptic manufacturing environments\n\nExposure to packaging validation, serialization, or automated inspection systems\n\nPrevious experience supporting FDA inspections or internal audits","datePosted":"2026-10-22T01:35:02.370Z","dateModified":"2026-10-22T01:35:02.370Z","hiringOrganization":{"@type":"Organization","name":"Sterling Engineering","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Wheeling","addressRegion":"IL","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"6454d2d41a1e8eb5a7255198"},"url":"https://jobsearcher.com/jobs/6454d2d41a1e8eb5a7255198"}}